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FDA ANDA · ANDA088389

LIDOCAINE

lidocaine hydrochloride and epinephrine bitartrate

Sponsor: DEPROCO

APPLICATION
ANDA088389
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-30
LATEST ACTION
2025-06-27
ROUTE
SUBMUCOSAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LIGNOSPAN FORTE · ReferencePrescription
EPINEPHRINE BITARTRATE EQ 0.02MG BASE/ML, LIDOCAINE HYDROCHLORIDE 2% · INJECTABLE · INJECTION

Approval history

2025-06-27Manufacturing (CMC) · Supplement 52 · unknown — Label ↗AP
2021-06-08Labeling · Supplement 47 · standardAP
2018-11-02Labeling · Supplement 43 · standardAP
2017-07-28Labeling · Supplement 36AP
2009-09-30OriginalAP
2007-06-29Labeling · Supplement 32AP
2004-10-04Labeling · Supplement 28AP
2000-04-06Manufacturing (CMC) · Supplement 21AP
2000-04-06Manufacturing (CMC) · Supplement 22AP
1996-03-04Labeling · Supplement 18AP
1994-08-04Manufacturing (CMC) · Supplement 17AP
1993-03-23Manufacturing (CMC) · Supplement 16AP
1993-02-09Manufacturing (CMC) · Supplement 15AP
1992-05-12Manufacturing (CMC) · Supplement 14AP
1992-05-11Manufacturing (CMC) · Supplement 13AP
1992-01-27Manufacturing (CMC) · Supplement 12AP
1988-05-05Labeling · Supplement 9AP
1987-06-08Manufacturing (CMC) · Supplement 8AP
1987-03-16Manufacturing (CMC) · Supplement 6AP
1986-01-14Manufacturing (CMC) · Supplement 5AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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